This study will evaluate whether co-administration of the first dose of V503 and REPEVAX™ is well tolerated and causes a non-inferior immune response when compared to administration of REPEVAX™ one month following the first dose of V503.

A Phase III Open-Label Clinical Trial to Study the Immunogenicity and Tolerability of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Given Concomitantly With REPEVAX™ in Preadolescents and Adolescents (11 to 15 Year Olds)

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:

Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 [ Time Frame: 4 weeks following Month 6 vaccination ] [ Designated as safety issue: No ]

Percentage of Participants With a V503 Injection-site Adverse Experience [ Time Frame: Day 1 through Day 5 following Day 1 vaccination ] [ Designated as safety issue: Yes ]

An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the vaccine is also an AE. Only injection-site AEs in the arm that received V503 vaccination were reported for this endpoint.

Percentage of Participants With a Repevax™ Injection-site Adverse Experience [ Time Frame: Day 1 through Day 5 following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination ] [ Designated as safety issue: Yes ]

For the Concomitant Vaccination group, injection-site AEs are reported following Day 1 vaccination; for the Non-concomitant Vaccination group, injection-site AEs are reported following Month 1 vaccination. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the vaccine is also an AE. Only injection-site AEs in the arm that received Repevax™ vaccination were reported for this endpoint.

Percentage of Participants With Maximum Temperature >=37.8 °C (>=100.0 °F) (Oral or Oral Equivalent) [ Time Frame: Up to 5 days following the Day 1 and Month 1 vaccination / visit ] [ Designated as safety issue: Yes ]

For the Concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 visit; for the Non-concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 vaccination.

Percentage of Participants With a Systemic Adverse Experience [ Time Frame: Up to 15 days following the Day 1 and Month 1 vaccination / visit ] [ Designated as safety issue: Yes ]

For the Concomitant Vaccination group, systemic AEs were collected after the Day 1 vaccination and the Month 1 visit; for the Non-concomitant Vaccination group, systemic AEs were collected after the Day 1 vaccination and the Month 1 vaccination. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body that is temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the vaccine is also an adverse experience. A systemic AE was an AE that was not associated with the injection site.

For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of neutralizing antibody to diphtheria toxin were measured using a cell-based Diphtheria Micrometabolic Inhibition assay. Serum titers of neutralizing antibody to tetanus toxin were measured using an enzyme immunoassay. The lower limits of quantitation of the assays was 0.01 International Units (IU)/mL and 0.04 IU/mL, respectively. Acceptable titers refer to the World Health Organization-defined protective titer of >=0.1 IU/mL.

For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of neutralizing antibody to poliovirus type 1, 2, and 3 were measured using a microneutralization assay. Serial dilutions of sera were incubated with type-specific standard poliovirus and sensitive cells. Neutralization of the virus was measured by cell staining. Acceptable titers were defined as neutralization at >=1:8 dilution of serum.

Secondary Outcome Measures:

Percentage of Participants Who Seroconvert for Each of the HPV Types [ Time Frame: Month 7 ] [ Designated as safety issue: No ]

V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1

V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1

Participant is not sexually active and does not plan on becoming sexually active during the study

Participant has received a documented full primary immunization series against diphtheria, tetanus, pertussis, and poliovirus (inactivated and/or oral poliovirus), but not in the last 5 years. There must be a 5-year interval from a prior vaccination containing any one of these vaccine antigens.

Exclusion Criteria:

Participant has a known allergy to any vaccine component of V503 or REPEVAX™

Participant has had a severe reaction affecting the brain (e.g., evolving encephalopathy) within 7 days after a previous dose of a pertussis-containing vaccine

Participant has had a progressive severe illness affecting the brain after a previous dose of tetanus, diphtheria, poliovirus or a component pertussis combination (acellular and whole cell) vaccine

Participant ever had Guillain-Barré syndrome or brachial neuritis following a previous dose of a tetanus-containing vaccine

Participant has a condition that is a contraindication to vaccination as indicated in the most up to date package inserts of REPEVAX™

Participant has a history of severe allergic reaction that required medical intervention

Participant has hemophilia, thrombocytopenia, is receiving anticoagulation therapy and/or has any coagulation disorder that would contraindicate intramuscular injections

Participant is concurrently enrolled in clinical studies of investigational agents

Female participant is pregnant

Participant has donated blood within 1 week prior to first study vaccination, or intends to donate during the study

Participant is immunocompromised, immunodeficient, or has an autoimmune condition

Participant has had a splenectomy

Participant has received immunosuppressive therapies in the prior year

Participant has received immune globulin product or blood-derived product in the last 3 months

Participant has received inactivated vaccine(s) within 14 days or live vaccine(s) within 21 days of first study vaccination

Participant has received a marketed HPV vaccine or has participated in an HPV vaccine trial

Participant has received a tetanus, diphtheria, pertussis, or poliovirus (inactivated and/or oral poliovirus) vaccination within the last 5 years

Participant has a fever ≥100°F within 24 hours of vaccination

Participant has any history or current condition, therapy, lab abnormality, or other circumstance such that it is not in the best interest of the participant to participate

Participant and parent/legal guardian are unable to give assent/consent

Participant is unlikely to adhere to the study procedures or is planning to relocate during the study

Participant has recent history of illicit drug or alcohol abuse

Participant has a history of HPV

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01073293